OPTICAL: Optimising Paediatric Transition to Intensive Care for AduLts

University College London (UCL) require access to NHS England data for the purpose of the following research project:

Optimising Paediatric Transition to Intensive Care for AduLts (OPTICAL)

The following is a summary of the aims of the research project provided by University College London (UCL):

OPTICAL aims to indirectly improve the quality of intensive care for young people with complex health needs by providing the first detailed understanding of the number and characteristics of patients who transition from paediatric to adult intensive care.

The primary objective of the OPTICAL study is to generate the evidence base for improving the care received and patient/family experience for teenagers transitioning from paediatric to adult ICU services.

The secondary objectives are-

1. To determine the clinical characteristics and healthcare resource utilisation from teenage years to early adulthood of people who used intensive care as a young person, and how these relate to intensive care use after the age of 16.

2. To understand the experience of patients, carers and health professionals of ICU transition, including barriers they face, examples of good practice and suggestions for improving support provided.

3. To establish evidence-based potential improvements in the processes and support for transitioning to adult ICU services, targeted among patient groups as appropriate.

4. Explore the outcomes of Teenage and Young Adult (TYA) admitted to PICUs for mental health (MH) crises in terms of their future need for adult critical care admission.

5. Understand the mental health implications of critical care transition from childhood to adulthood on the individual, their families, and healthcare professionals involved in their management.

To support these objectives, the study makes extensive use of national audit datasets from the Paediatric Intensive Care Audit Network (PICANet) and the Intensive Care National Audit & Research Centre Case Mix Programme (ICNARC CMP). These datasets provide comprehensive, longitudinal data on paediatric and adult ICU admissions, respectively.

The data from NHS England will contribute to objective 1 for data analysis and the findings from the analysis will contribute to objective 3.

Objective 1 and objective 3 do not involve recruiting participants. The participants for objective 1 are identified by

1) The Hospital Episode Statistics Critical Care Dataset which defines the critical care population,

2) The Paediatric Intensive Care Network (PICANet), and

3) The Intensive Care National Audit & Research Centre Case Mix Programme (ICNARC CMP).

The integration of PICANET and ICNARC records with Hospital Episode Statistics Critical Care (HES CC) data enables the identification and characterisation of young people who transition between ICU services, supports the analysis of patterns and risk factors associated with ICU use after age 16, and informs the development of targeted improvements in transition pathways.

Objective 3 does not involve a study population or recruitment. It involves establishing an expert group to review evidence relating to the management of ICU transition. Objective 4 involves sub group analyses of the datasets from objective 1, and additional participant recruitment for work package 2 (which does not involve the NHS England data).

This study aims to produce the evidence base for the development of future national guidelines to improve the care and experience of teenagers transitioning from paediatric to adult ICU services. This involves generating evidence on:

• The size and characteristics of the population that require transition from paediatric to adult intensive care post 16

• Whether certain conditions make AICU admission more likely

• Whether this population can be identified during childhood and the methods to do this

• The types and number of hospital interactions these teenagers and young adults (TYA) have including current outcomes

• The lived experiences of Teenage and Young Adult (TYA) and their families, and health professionals involved in paediatric to adult ICU transition

• The ways in which clinical care and patient experience can be improved

Measuring, reporting and learning from outcomes should drive quality improvement of care but this is particularly challenging for conditions or health problems such as learning disabilities, mental health issues, genetic syndromes, and congenital anomalies. Given the complex care trajectories and experiences of patients with chronic complex conditions, rich datasets and careful multi-disciplinary analysis is required.

The following NHS England data will be accessed:

Hospital Episode Statistics (HES) - necessary to complete the patient trajectories of healthcare use, diagnoses, and treatment

• Critical Care (CC) necessary to establish a cohort of patients admitted to intensive care.

• Outpatients (OP)

• Accident and Emergency (A and E)

• Admitted Patient Care (APC)

• Emergency Care Dataset (ECDS)

• Civil Registrations of deaths necessary to determine loss to follow up and also to include in healthcare analyses

The level of the data will be Pseudonymised.

The Data will be minimised as follows:

- Limited to a study cohort identified by NHS England as meeting the following criteria:

All patients with at least one critical care admission in England aged 14- or 15 years between January 2017 and March 2024 (allowing at least one year of follow up), captured in the Hospital Episode Statistics Critical Care dataset.

- For individuals in the HES Critical Care cohort identified by NHS England, data is limited to 2003/04 up to latest available for HES APC, HES OP, HES A&E and ECDS. For HES CC, data is limited from January 2017 up until latest available.

- Civil registrations mortality will contain latest available data.

UCL is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e): processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The processing is in the public interest because the research aims to deliver significant benefits to young people transitioning from child to adult ICU, and their families, by generating the crucial evidence that will enable improvement of clinical care and experience at a time of heightened vulnerability. The new evidence will also deliver benefits to the NHS by empowering staff to identify and better support this relatively small but rapidly increasing population, who use scarce and high-cost intensive care resources.

Funding is provided by the National Institute for Health Research (NIHR). The funding is specifically for the project described

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL’s Data Safe Haven.

UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

Data will be assessed by:

- Substantive employees of UCL; and

- Individuals holding an honorary contract under the supervision of a substantive employee of University College London for the purposes described in this Data Sharing Agreement (DSA) only. University College London must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

• Their substantive employer;

• Their role in respect of the purpose for the processing specified in the DSA;

• The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

• The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

• Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

One parent/carer with first-hand experience of transition to AICU (PPI co-applicant) provided feedback on the proposal and will chair our PPI group. Additionally, UCL's partner paediatric patient charities ICUSteps, WellChild and Mencap will help with objective 2 of the study (e.g. designing online forums). These charities develop and moderate the forums, and representatives from each advise across the study via the PPI group.

For objective 2, the study team and charities will engage with potential participants for the 1:1 interviews, surveys, and online forums for i) Teenage and Young Adult (TYA) who have had a PICU admission ii) family members of Teenage and Young Adult (TYA) who have had a PICU admission. Objective 2 does not involve the NHSE data.

No data will flow to NHS England

NHS England will identify a cohort (as detailed in section 5a of this DSA) using HES CC.

NHS England will provide the relevant records from the HES CC, APC, HES OP, HES A&E, ECDS and Civil Registration Death and datasets to UCL. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

Under a separate DSA (DARS-NIC-791298-B8B2B) ICNARC will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Name, Date of Birth, Postcode, Gender and a unique person ID).

Under a separate DSA (DARS-NIC-791292-Z2X6Z) Healthcare Quality Improvement Partnership (HQIP) will transfer a PICANet cohort to NHS England. The data will consist of identifying details (specifically NHS Number, Name, Date of Birth, Postcode, Gender and a unique person ID)

For both the PICANet and ICNARC cohorts NHS England receive, NHS England will supply two files to UCL containing pseudonymised study IDs, these files will allow UCL to identify (at a pseudonymised study ID level) whether an individual identified in the HES CC cohort identified by NHS England is also present in the ICNARC or PICANet cohorts and If present UCL will also have access to the HES, ECDS and Civil Registration of deaths data.

The Data will not be transferred to any other location.

Data is stored on servers at UCL.

Amazon Web Services provides cloud hosting services to UCL and will store the data as contracted by UCL.

The Data will be accessed by authorised personnel via remote access. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England/Wales. The data will not leave England/Wales at any time.

Data will be accessed by individuals substantively employed by UCL and individuals with an honorary contract with UCL. The individual(s) will act as an agent of UCL at all times under supervision from employees of UCL. Aside from this/these individuals, access is restricted to employees or agents of UCL who have authorisation from the Principal Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with pseudonymised data obtained from the ICNARC and PICANET databases respectively, which is stored within the UCL Data Safe Haven. The linkage will exclusively be for individuals within the HES Critical Care cohort who also have records within the ICNARC and PICANET data. These linkages will be carried out using pseudonymised Study IDs.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts from UCL will process/analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• Academic articles, including the study protocol (published in open-access journals to improve transparency of reporting)

Approximately ten publications in peer-reviewed Medical and Scientific Journals, oral and written presentations at national and international conferences. The final outputs will only contain aggregate results with small number suppression, in line with the HES Analysis Guidelines.

• Conference presentations (e.g., UK Paediatric Critical Care Society (PCCS) Annual Conference, Intensive Care Society (ICS) State of the Art meeting)

• Webinars to present study findings (e.g., through the professional societies and Royal Colleges).

• One-page executive summaries.

• Social media posts (including LinkedIn), accessible lay summaries, blogs, vlogs, infographics, slide decks, newsletters and podcasts (disseminated through our study website and partner organisations).

• Code mapping tables from objective 1 and interview topic guides and surveys from objective 2 will be additional study outputs.

• Informing and engaging patients, NHS and wider population about the work undertaken.

To transfer the new measures into practice the study team will use the networks of their team and experts from their committees.

The research team has strong links with the UK Paediatric Critical Care Society (PCCS) and the Intensive Care Society. UCL also have strong links with paediatric care charities to capture their perspectives through online forums as patient and family views are crucial. Charities include the Royal Mencap Society, ICUSteps, and WellChild.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

· Webinars - UCL will submit annual reports (most recently May 2024) to the NIHR (the project funders) and partner with them to draw on their networks and skills in dissemination and spread to make an impact more widely, which may include generating accessible resources such as downloadable leaflets and case studies, research highlights, blogs and webinars

· Social media - A project website https://www.ucl.ac.uk/clinical-operational-research-unit/optical-study, and via social media and blogs. Updates to the website will be ongoing throughout the study and as and when publications and communications are available. Updates will be less common following the final publication, however the timing of the final communication is not possible to determine as updates on benefits or reviews may be made after the study end and final publication. UCL will also publish details of OPTICAL on the PICANet and ICNARC websites as well as on the UCL CORU website.

· Participant newsletters - The team will also arrange the dissemination of findings through the charities the Royal Mencap Society, ICUSteps, and WellChild who will send newsletters to members and news items on its website highlighting the work of the study to its members. . Where appropriate, results will be promoted as press releases (2026-2030)

· Reports aimed at [participants/patients] - UCL will ensure that lay summaries are provided (reviewed in collaboration with patients and parents on their PPI Committee). The patients and parents on the advisory committee attend annual advisory group meetings to receive updates and to provide feedback on any aspect of the study

The target dates for production and dissemination of the outputs are over the course of the DSA 2025-2028

OPTICAL will aim to deliver significant benefits to young people transitioning from child to adult ICU, and their families, by generating the crucial evidence that will enable improvement of clinical care and experience at a time of heightened vulnerability. It is hoped that the new evidence will also deliver benefits to the NHS by empowering staff to identify and better support this relatively small but rapidly increasing population, who use scarce and high-cost intensive care resources.

OPTICAL is focused on the evidence needed to inform practice, with objective 3 designed to ensure that the quantitative and qualitative data collected in objectives 1 and 2 is fit for that purpose, and that the new evidence will be synthesised and used by stakeholders to develop practical evidence-based suggestions for improving transition services.

Importantly, objective 3 will ascertain whether certain improvements can be customised or targeted for particular patient groups in order to ensure that limited NHS resources are focused where they are needed most, maximising patient benefit and value for money.

The researchers expect to enable clear pathways to impact that will maximise the potential benefits of the work by:

* Directly informing updates to the current Intensive Care Society (ICS) / Paediatric Critical Care Society (PCCCS) joint transition guidelines through a co-investigator who is lead author of the guidelines and ICS Council Member and another who is Director of Research at ICS.

* Directly informing quality standards for the care of critically ill children through our co-principal Investigator who is PCCS research group chair and Council Member.

* Incorporating learning from the implementation of transition guidelines in testbed regions through a co-investigator who is paediatric critical care network lead in Yorkshire, where a scheme is being updated based on feedback from clinicians and patients.

Yielded Benefits is not a requirement for new applications.